Breast Implants - A Brief History

Below is a brief history of Breast Implants and
Breast Augmentation in general. All
FDA approved Breast Implants that are currently available in the US are featured, as well as many of the Breast Implants that preceded them. It is not meant as an exhaustive
listing of all Breast Implants, as several popular past choices are not mentioned for clarity.

2012 marked the entry of a new US based and FDA approved Breast Implant manufacturer. Long time US Breast Implant manufacturers, Natrelle® (Allergan) and
Mentor® (J&J) where joined by new comer Sientra® (Silimed). Sientra® (Silimed) brings
the first FDA approved high-strength silicone gel filled, "gummy bear" teardrop shaped breast implants to the US market. Sientra® uses this soft, form-stable
silicone gel in all their implants. sometimes refered to as "gummy bear" breast implants. Natrelle® (Allergan) and Mentor® (J&J)
have since recieved approval for their own versions of shaped silicone gel implants: Natrelle's® style 410 and Mentor's®
CPG line, respectively.

Before Breast Implants

1889 – Surgeon Robert Gersuny tried using paraffin and vaseline injections to increase the size of the breasts, while the breast were larger,
the results were disasterous. Paraffin augmented breast became hard, and the breasts experienced a severe chronic and disfiguring inflammatory response.

1895 – Vincenz Czerny transplanted fat from the lower back to the breasts. A benign fatty tumor, called a lipoma, was
removed from the lower back and placed in the breast to reconstruct a breast defect originally caused by removing a breast tumor. Thus, fat grafting
precedes Breast Implants for Breast Augmentation by at least 67 years.

1945 – Morton Berson performed a rotational flap to increase the volume of the breast.

1950 – Jacques Maliniac performed a rotational flap to increase the volume of the breast.

1950-1960's – Free silicone was injected into the breast with good results initially, and later disastrous results due to
the formation of silicone granulomas and breast hardening, sometimes severe enough to require a mastectomy for treatment.

The First Breast Implants

1961 – the American plastic surgeons Thomas Cronin and Frank Gerow, and the Dow Corning Corporation, developed the first
silicone breast prosthesis, filled with silicone gel.

1962 – The first augmentation mammoplasty was performed in 1962 using the Cronin-Gerow Implant, prosthesis

1964 – The French company Laboratories Arion developed and manufactured the saline breast implant, filled with saline

1976 – US Congress passes the 1976 Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act. Breast Implants
are classified as moderate risk (Class II) devices and required to comply with general controls and performance standards. The FDA reviews
new breast implants through the 510(k) premarket notification process.

1992 – The FDA decides that the manufacturers had not adequately addressed public concerns about certain complications.
Rather than selecting the devices with a poor record, the FDA removes all silicone gel filled breast implants from the market; however the ruling
applies only for elective cosmetic breast augmentation. The FDA continues to allow manufacturers to provide silicone gel filled implants
for breast reconstruction after mastectomy, correction of congenital deformities, replacement of existing implants and for breast augmentation
performed in conjunction with a breast lift.
The Breast Implant Adjunct Studies were created, so that data could be collected about device performance and safety in large
groups of women. In order to make breast implants again available for elective cosmetic breast augmentation, the FDA requires manufacturers to
submit premarket approval applications that contained data on safety and effectiveness – like a new product. Europe follows the lead, but
removes restrictions after a few months, after reviewing the available literature and finding no links to serious systemic health issues.

1993 – The next generation of Breast Implants (Allergan Style 410 and Mentor Contour Profile Gel), textured,
anatomic, highly cohesive (nearly form stable), silicone gel filled breast implants are complete, tested, and ready for submission for FDA studies
in the United States and Europe … and Europe takes the lead with early approval.

1999 – The Institute of Medicine (IOM) releases a comprehensive report of the published literature and ongoing studies on
breast implants, entitled Safety of Silicone Breast Implants. The study concludes that there is no evidence that silicone breast
implants cause systemic health effects, such as cancer or autoimmune disease. Local complications (infection, bleeding, pain, deflation,
capsular contracture, additional surgery) remain the primary safety issues with silicone breast implants.

2006 – The FDA approves AllerganÕs Natrelle Silicone Gel Filled Breast Implants and MentorÕs MemoryGel Silicone Gel Filled
Breast Implants. The FDA based its approvals on the manufacturersÕ Core Studies. These clinical PMA studies followed hundreds of women with
Silicone Gel Filled Breast Implants for 4 years (Allergan) or 3 years (Mentor). The FDA determines that silicone filled breast
implants are safe and effective. They further concluded that the benefits and risks of breast implants were sufficiently well understood for
women to make informed decisions about their use.
As conditions of approval, the FDA requires both Allergan and Mentor to conduct six post-approval studies to investigate the long-term
performance and safety of their silicone gel filled breast implants. From the FDA’s site these studies are:

Core Post-Approval Studies (Core Studies) – To assess long-term clinical performance of breast implants in women that
enrolled in studies to support premarket approval applications. These studies were designed to follow women for 10 years after initial implantation.

Large Post-Approval Studies (Large Studies) – To assess long-term outcomes and identify rare adverse events by enrolling
more than 40,000 silicone gel-filled breast implant patients and following them for 10-years.

Device Failure Studies (Failure Studies) – To further characterize the modes and causes of failure of explanted devices
over a 10-year period.

Focus Group Studies – To improve the format and content of the patient labeling.

Adjunct Studies – To provide performance and safety information about silicone gel-filled breast implants provided to U.S.
women from 1992-2006, prior to approval, when implants could only be used for reconstruction and replacement of existing implants.

2011 – The FDA releases the Update on the Safety of Silicone Gel-Filled Breast Implants. The conclusion: breast implants,
while not perfect, remain safe and effective. The most common problems associated with breast implants remain: capsular contracture, reoperation
and implant removal (with or without replacement). Other frequent complications include: implant rupture, wrinkling, asymmetry, scarring, pain,
and infection, among others. These observations are consistent with the local complications and adverse outcomes that were known at the time of
approval, and there remains no apparent association between silicone gel filled breast implants and connective tissue disease, breast cancer,
or reproductive problems.

2012 – The FDA approves the first High-Strength (aka Gummy Bear) Silicone Gel Filled Breast Implants for the US.
Nearly two decades after Europe approves the change to a soft, "solid" gel filler with remarkably low failure rates, the US catches up. Somewhat
surprisingly, the first company to receive approval is a new company, Sientra, rather than Allergan or Mentor. Like its rivals, Sientra is based in
Santa Barbara, California, United States. The company contracts with long-time breast implant manufacturer Silimed for its manufacturing.
The move to form-stable fillers makes possible the manufacture of soft, solid, shaped implants, that can better maintain lower pole fullness
for breast reconstruction and the treatment of congenital breast defects like
Tubular Breasts and
Poland Syndrome.

2013 – In February, the FDA approves Allergan's version of the shaped, highly cohesive (gummy bear). In June, the FDA approved
Mentor's CPG line of textured, shaped breast implants. Allergan's 410 series and Mentor's CPG line are a collection of breast implants of independently
varying height, width and projection. This allows your Board Certified Plastic Surgeon to have a wider selection of options when choosing the best
shapes and sizes when a shaped implant is desired. Each of these tear-drop shaped breast implants is fuller at the bottom (as long as they don't rotate!).

Regulatory History – Additional information in the regulatory history of breast implant in the US is available on the
FDA web site.

Currently Available Breast Implants

Breast Implants come in hundreds of shapes, sizes and contours, making customization of results more practical. If you are looking
for the fine details of today's Breast Implants, be certain to visit our
Currently Available Breast Implants Page.
There you find listings of the types, sizes, dimensions, contours, profiles and fillers available from the three current US Breast Implant makers. Full catalogs from
Natrelle® (Allergan), Mentor® (J&J) and Sientra® (Silimed) are available to view.

Natrelle® (Allergan) Breast Implants

Natrelle® (Allergan) – Allergan offers a full line of both Saline filled Breast Implants
and Cohesive Silicone Gel filled Breast Implants. Both saline and silicone gel filled implants are available as round and teardrop shaped and come in a variety of profiles and dimensions.
Allergan is the manufacturer, and their Breast Implants are marketed under the brand name Natrelle®. Their texturing process is called
BioCell®.

Mentor® (J&J) Breast Implants

Mentor® (J&J) – Mentor® also offers a complete line
of Breast Implants including both Saline filled Breast Implants and Silicone filled. Mentor's® Silicone Breast
Implants are marketed under the brand name MemoryGel®, and their textured Breast Implants are marketed as
Siltex®.

Sientra® (Silimed) Breast Implants

Sientra® (Silimed) – Sientra® is the newest company to
offer FDA approved Breast Implants. They do not have a Saline filled Breast Implant line. Sientra® offers smooth round,
textured round and textured shaped Silicone Filled Breast Implants. Their textured Breast Implants are marketed as TRUE Texture™
The aggresiveness of Sientra's TRUE Texture™ texturing is about half way between Natrelle's® more
aggressive BioCell® texturing, and Mentor's® less aggressive
Siltex® texturing.

They are the first US company use a high strength silicone gel filler in their Breast Implants. This type of implant has been available outside the US
for several years, and is sometimes referred to as the Gummy Bear Breast Implant. The high strength gel provides stability of form and
allows Sientra® to manufacture the first FDA approved teardrop shaped silicone gel Breast Implants in the US.

The same high strength gel used in the textured teardrop shaped Breast Implants is also used in their Round Breast Implants. Recently released 5-year
data shows that the leakage rate for these Silicone Breast Implants is about half that seen in the PMA data of previous manufacturers.
The reported 5-year gel migration rate is a very reassuring 0%.

What’s Next in Breast Implants

Now that the Gummy Bear, High-Strength, Form-Stable Silicone Breast Implants are available, what's next? San Francisco Bay Area Breast Augmentation
patients and Plastic Surgeons alike, want to know. The latest generation of breast implants provide for a reduction in one of the most frequent reasons for
Breast Implant Revision Surgery -
deflation. Since the centers are a soft solid, the new high-strength silicone gel resists migration. Even when the shell develops a rent, the filling is less likely
to migrate outside the capsule.

Capsular Contracture
rates declined with the advent of cohesive silicone gel and low-bleed shells. Perhaps, the next generation of breast implants will have a coating which further
reduces the risk of capsular contracture.

Larger implant sizes. While this is problem for a minority of
Breast Augmentation patients,
larger breast implant volumes are needed for some Breast Reconstruction patients. Currently, matching procedures like a breast lift or a breast reduction, are performed
on the opposite breast during breast reconstruction. If larger breast implant volumes where available, fewer matching breast reductions would be needed.